ISPAM September 6 2014 Meeting - page 79

Comments on the Detection of Salmonella SMPR
3
88
Relocate (D-glucose) with the other sugars.
This is the
verbatum
description from the
Bergey
et al
manual. See reference at entry.
No change proposed.
101
"A test portion can be used in validation
studies when appropriate." What does this
mean? Unclear.
The word "different" between "A" and "test
portion" was inserted to correct the
statement.
Revised in version 14
109-110
UCL usually means upper confidence limit.
Agreed.
Revised in version 14
127
"Use pre-harvest materials for method
evaluation. Do not use processed materials" is
unclear.
No change proposed, but suggestions are
welcomed.
No change proposed, but
suggestions are
welcomed.
141 Specify XX hrs.
The working group agreed to specify 24 hours
as the maximum time.
Revised in version 14
131 Suggest deleting if the time cannot be agreed
upon.
The working group agreed to specify 24 hours
as the maximum time.
Revised in version 14
Table 1
It is unclear why a reiteration of method
validation requirements is necessary for this
document. This might actually lead to
unnecessary confusion. For example, how is it
different than other method validation
guidelines? I would recommend deleting the
method validation guidelines and refer to the
preferred document, e.g., AOAC or ISO
guidelines. When considering that there is
significant current interest in harmonizing
method validation guidelines internationally, it
remains unclear why these guidelines are being
elaborated.
This issue has been thouroughly discussed
several times. The current AOAC validation
system requires that an Expert Review Panel
use an SMPR as a basis for adoption as an
AOAC method, therefore the criteria must be
included. A validation guideline describes the
validation process, an SMPR describes the
accetpance criteria which are generally not
included in validation protocols, and may be
application specific. AOAC and ISO guidelines
do not provide specific acceptance criteria.
SMPRs should not effect harmonization, but
rather codify the minimum expected results.
No change proposed.
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